BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR ENDOBRONCHIAL VALVE (EBV)

    MDR report key: 11682129 · Received April 16, 2021

    Report

    Report Number
    3007797756-2021-00062
    Event Type
    Injury
    Date Received
    April 16, 2021
    Date of Event
    March 18, 2021
    Report Date
    April 14, 2021
    Product Code
    NJK
    UDI-DI
    00811907030126
    PMA / PMN Number
    P180002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PNEUMOTHORAX IS THE MOST COMMON SIDE EFFECT ASSOCIATED WITH THE ZEPHYR VALVE TREATMENT (CRINER ET AL. A MULTICENTER RANDOMIZED CONTROLLED TRIAL OF ZEPHYR ENDOBRONCHIAL VALVE TREATMENT IN HETEROGENEOUS EMPHYSEMA (LIBERATE). AM J RESPIR CRIT CARE MED. 2018; 198 (9): 1151-1164). TARGETED LOBAR DEFLATION LIKELY CAUSES INFLATION OF THE IPSILATERAL LOBE, WHICH CAN RESULT IN A TEAR OF THE ALREADY COMPROMISED PARENCHYMAL TISSUE OF THE EMPHYSEMATOUS IPSILATERAL LOBE, RESULTING IN A PNEUMOTHORAX (CRINER ET AL. A MULTICENTER RANDOMIZED CONTROLLED TRIAL OF ZEPHYR ENDOBRONCHIAL VALVE TREATMENT IN HETEROGENEOUS EMPHYSEMA (LIBERATE). AM J RESPIR CRIT CARE MED. 2018; 198 (9): 1151-1164). IN THE LIBERATE STUDY (IDE CLINICAL STUDY USED TO SUPPORT PMA P180002'S APPROVAL), 26.6% OF THE ZEPHYR VALVE SUBJECTS EXPERIENCED A PNEUMOTHORAX IN THE TREATMENT PERIOD ([LESS THAN OR EQUAL TO 45 DAYS). THESE WERE MANAGED USING STANDARD OF CARE PROCEDURES AS PER PREVIOUSLY PUBLISHED GUIDELINES (VALIPOUR, ARSCHANG, ET AL. RESPIRATION 87.6 (2014): 513-521). IN 17.4% OF THE EVENTS, THE PNEUMOTHORAX RESOLVED WITHOUT ANY ADDITIONAL INTERVENTION WITH SUBJECTS UNDER CAREFUL OBSERVATION. IN OVER HALF THE EVENTS (56.5%), THE PNEUMOTHORAX WAS MANAGED WITH A CHEST-TUBE ONLY. AN ADDITIONAL 13% OF THE EVENTS WERE MANAGED WITH A CHEST-TUBE AND THE TEMPORARY REMOVAL OF ONE OR MORE VALVES, WHILE ANOTHER 13% OF THE EVENTS WERE MANAGED WITH A CHEST-TUBE AND REMOVAL OF ALL THE IMPLANTED VALVES. UPON SUCCESSFUL RESOLUTION OF THE PNEUMOTHORAX, REMOVED VALVES CAN BE REPLACED. PATIENTS THAT EXPERIENCED A PNEUMOTHORAX EXPERIENCED CLINICAL BENEFITS OF THE ZEPHYR VALVE TREATMENT THAT WERE SIMILAR TO THE BENEFITS EXPERIENCED BY PATIENTS WHO DID NOT HAVE A PNEUMOTHORAX. THE ZEPHYR EBV SYSTEM IFU AND PULMONX TRAINING PROGRAM BOTH SPECIFICALLY REFERENCE PNEUMOTHORAX AS A KNOWN SIDE EFFECT OF THIS PROCEDURE AND THE PUBLISHED GUIDELINES (VALIPOUR, ARSCHANG, ET AL. "EXPERT STATEMENT: PNEUMOTHORAX ASSOCIATED WITH ENDOSCOPIC VALVE THERAPY FOR EMPHYSEMA-POTENTIAL MECHANISMS, TREATMENT ALGORITHM, AND CASE EXAMPLES." RESPIRATION 87.6 (2014): 513-521). THE REPORTED EVENT ALIGNS WITH THE EXPERIENCE OBSERVED IN THE LIBERATE CLINICAL STUDY AND IS AN EXPECTED SIDE EFFECT TO THE ZEPHYR VALVE TREATMENT. ONE ZEPHYR 4.0 VALVE WAS REMOVED; THE LOT NUMBER OF THE VALVE IS UNKNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2020, PATIENT UNDERWENT BRONCHOSCOPIC PROCEDURE AND HAD FOUR ZEPHYR VALVES PLACED. PATIENT HAD A PNEUMOTHORAX POST PROCEDURE AND ONE VALVE WAS ULTIMATELY REMOVED. ON MAR. 15, 2021, PATIENT UNDERWENT BRONCHOSCOPIC PROCEDURE AND TWO ADDITIONAL ZEPHYR 4.0 VALVES WERE PLACED. PATIENT WAS ADMITTED TO OBSERVATION POST PROCEDURE AND WAS DISCHARGED HOME ON (B)(6) 2021. AFTER A FEW HOURS, PATIENT DEVELOPED SUDDEN CHEST PAIN AND RESPIRATORY DISTRESS, WAS ADMITTED AT AN OUTSIDE HOSPITAL WHERE THE PATIENT WAS INTUBATED AND ONE PIGTAIL CATHETER WAS PLACED. ON (B)(6) 2021, PATIENT WAS TRANSFERRED TO HOSPITAL WHERE ZEPHYR VALVES WERE PLACED, AND AN ADDITIONAL RIGHT ANTERIOR CHEST TUBE WAS PLACED FOR PERSISTENT PNEUMOTHORAX. THE PATIENT WAS EXTUBATED, AND THE RIGHT UPPER LOBE (RUL) APICAL AND POSTERIOR VALVES WERE REMOVED WITH BRONCHOSCOPY. THE RUL AND RIGHT MIDDLE LOBE ENTRANCE VALVES REMAIN IN THE PATIENT. ON (B)(6) 2021, THE RIGHT ANTERIOR CHEST TUBE WAS REMOVED. ON (B)(6) 2021, CHEST TUBE WAS PLACED ON WATER SEAL. ON MAR. 29, 2021, THE RIGHT LATERAL CHEST TUBE WAS REMOVED. ON (B)(6) 2021, PATIENT WAS DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579153 ZEPHYR ENDOBRONCHIAL VALVE (EBV) ENDOBRONCHIAL VALVE NJK ZEPHYR 4.0 EBV 504809-V7.0 00811907030126

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R